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Most device designers are well aware of the importance of human factors during product development. As more products allow users to manage information, whether it’s a clinician sharing data from device to device within a hospital, or a patient tracking compliance with a therapeutic routine, there is a higher expectation for user interface quality and interoperability.

“When considering human factors more holistically, you have to think not just about a device working alone, but also how it fits within a system that includes other devices, and whether the various devices have good interoperability,” says Michael Wiklund, general manager, UL-Wiklund (UL’s human factors engineering group). “A device has to play well with others.”

In a Q&A with MedTech Intelligence, Wiklund discusses how manufacturers should be approaching human factors from an investment, product development, and application standpoint.

MedTech Intelligence: What challenges do manufacturers face related to assessing the user experience and identifying risks associated with product design?

Michael Wiklund: Best practice suggests applying human factors from the start of a development effort. If developers do not do this, and perhaps have not even conducted preliminary usability tests of the product, they are likely to have problems validating the device’s use-safety. They’ll likely discover design shortcomings that could have been caught much earlier in the development process or avoided all together. Often, developers perform back-filling activities to ensure a complete design history file, but they’re doing the work, such as conducting user research to write user interface requirements and performing a use-related risk analysis, when the product is nearly finished. This timing limits opportunities for the human factors engineering work to positively influence the final design.

During a validation usability test aligned with FDA’s expectations, people perform critical tasks with a given device. The tasks are those that could lead to harm if the user makes mistakes, but presumably are unlikely to occur due to risk control measures. Mistakes signal user interface design flaws that might have been detected earlier in the development process through preliminary testing.

MTI: Why should manufacturers consider human factors an investment rather than a cost?

Wiklund: Companies should be thinking about human factors as an investment, just as they think of investing in any other qualities, such as reliability. Of course, they need to meet the regulatory minimums. Beyond that, they are justified in thinking about how an extra investment in human factors might pay off, just as an investment in industrial design might pay off. When you invest in human factors, you have a right to expect that your devices will deliver a good user experience.

Manufacturers should be making investments in human factors for regulatory and commercial reasons, and they should expect significant ROI. Accruing benefits might include greater sales volume because people find the product intuitive to use; fewer calls to customer support because people are not struggling to use it; simpler user documentation because the device’s use is simpler to explain; and reduce product liability exposure because the device is demonstrably less prone to potentially harmful use errors.

If you produce a device with a great user interface, you might be able to sell it for many more years, rather than being forced to replace it after a few years because a competitor has introduced a more user-friendly device.

MTI: What application areas are ahead of the curve?

Wiklund: I consider many of today’s minimally invasive surgical instruments to be exquisitely well designed. Many of them are wonderful examples of ergonomic design.

I also admire many of what I will call hybrid devices that have both hardware and software user interface elements. For example, there are some dialysis machines, patient monitors, defibrillators, and other equally complex medical devices that are easy to learn and use in a safe and effective manner, largely due to an investment in human factors engineering.

MTI: Home healthcare is growing. Do you see an evolution in how human factors will play into this space?

Wiklund: Devices we normally think of being used by nurses and other healthcare providers are now used by laypersons at home; perhaps the parent of a young child or one elderly spouse helping another. Increasingly complex medical devices are moving into the home partly to reduce the cost of healthcare, to keep people out of hospitals where we know they can contract infections, and to give people more control over their own healthcare. For example, my team was involved in the development of a hemodialysis machine that laypeople will use at home, thereby saving a lot of commuting time and potentially improving their health through more frequent but shorter treatments.

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About The Author

Maria Fontanazza has more than a decade of experience in journalism, marketing, and communications within the medical device industry. She was previously marketing communications manager and market research manager at Secant Medical, Inc., a manufacturer of biomedical textiles and advanced biomaterials. Fontanazza was also an editor at MD+DI and has authored more than 350 articles that have appeared in domestic and international industry publications. Fontanazza has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT. Follow her industry insights on Twitter at @MariaFontanazza. Contact Maria

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Patrick Caines is director, quality & post-market surveillance at Baxter Healthcare where he is responsible for the company’s global post-market surveillance and associated quality systems. Caines has 20 years’ experience in quality systems and compliance for both medical devices and clinical diagnostics and served as director, corporate post-market surveillance at General Electric Healthcare and Boston Scientific, and director of worldwide customer quality at Johnson and Johnson. Caines began his career as a hospital-based clinical laboratory scientist and held faculty appointments at the University of Windsor and Wayne State University. He holds a Ph.D. in clinical biochemistry from the University of Windsor, Ontario, Canada as well as an MBA from St. John Fisher College, Rochester, New York.

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Tony Blank is cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Immediately prior to forming Barton & Blank, Blank spent 12 years at Boston Scientific Corp. in both corporate and business regulatory leadership roles. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups—including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of regulatory affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Blank has worked with cardiopulmonary, surgical, ophthalmic, vascular access and critical care medical devices.

Alberto Velez is a consultant for Chimera Consulting North America, LLC. Velez is a recognized expert in organization development for combination products with more than 12 years of experience in applying CGMP concepts to more than 35 combination products in new product development, manufacturing and quality systems. He is a frequent speaker on combination products topics at industry meetings and has more than 30 years of varied experience in medical device and combination product quality assurance, FDA readiness, product development and organizational effectiveness in the pharmaceutical and medical device industries. Velez has applied the CGMP’s/QSR’s to several different divisions in the Johnson & Johnson family of companies as well as other smaller medical device companies. He has also led R&D teams to develop and launch new technologies in endoscopic surgery and enteral feeding. His educational background is in chemical engineering, industrial engineering and quality engineering.

Stephen Wilcox, Ph.D., FIDSA is a principal and the founder of Design Science (Philadelphia), a 30+ person firm that specializes in optimizing the usability of products, particularly medical devices for clients including many major multinational corporations. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He also served for several years as Chair of the IDSA Human Factors Professional Interest Section.

Wilcox also serves on the Advisory Boards of the Industrial Design Department of Philadelphia University and the School of Design of Carnegie Mellon University, on the Human Factors Engineering Committee of AAMI, and on the ISO/IEC committee (“Working Group 4”) that wrote the standard, IEC/ISO 62366. He holds a BS in psychology and anthropology from Tulane University, a Ph.D. in experimental psychology from Penn State, and a Certificate in Business Administration from the Wharton School of the University of Pennsylvania. He has won a number of design awards, has guest edited the journal Innovation several times and has served as a judge for a number of product design award competitions.

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Mark Leimbeck is the principal of UL Solutions Risk Management Practice. He has served as a subject matter expert and advisor in a number of functional areas, including risk management, quality management, project management, software application development, and engineering. During his career, Leimbeck has led and supported the implementation of various corporate improvement and development programs including quality system and regulatory compliance programs, new product development, IT systems and enterprise resource planning (ERP) implementation, and quality/lean Six Sigma process improvement projects. Leimbeck continues in a subject matter and advisory role, and participates in international, national and industry-based standards and guidance development committees. He holds a B.S. E.E.T. from Southern Illinois University and an M.B.A from the University of Chicago.

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